Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05059353
Other study ID # NG-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2021
Est. completion date August 31, 2022

Study information

Verified date October 2022
Source Neuroglee Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is designed to evaluate the preliminary effectiveness and safety of a digitally based multidomain intervention in patients with MCI. In addition, a portion of cognitively normal subjects and caregivers of patients with MCI will also be recruited as an exploratory cohort. We hope that the digital platform will improve the overall cognition and quality of life in patients with MCI.


Description:

3 groups of participants will be recruited. For the participants in the MCI (group A) and cognitively normal subjects (group B), they will be provided with a digital tablet and a wearable device. The digital tablet will be pre-loaded with 10 modules, 1 module per week (1 hour) for 10 weeks to be completed at home. The wearable device will be used to track and collect physiological data. For the caregivers of the patients with MCI (group C), they will be asked to complete a questionnaire during screening visit and follow-up visit, and to use the caregiver app during the intervention period.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date August 31, 2022
Est. primary completion date August 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 70 Years
Eligibility Patients with MCI Thirty (30) patients with MCI of the amnestic type (single or multi domain) will be recruited. MCI will be diagnosed using the Petersen's criteria and/or the NIA-AA criteria by cognitive neurologists. Inclusion criteria: 1. Either male or female aged between 50 and 70 years (inclusive) 2. Diagnosis of amnestic MCI using the Petersen's criteria and/or the NIA-AA criteria 3. Clinical Dementia Rating (CDR) score of 0.5 and Mini-Mental State Examination (MMSE) >24 4. Education >6 years 5. Literate in English 6. Basic proficiency in using web-based applications/mobile platforms 7. Willing to give informed consent Exclusion criteria: 1. Significant hearing or visual impairment 2. Significant systemic, neurological or psychiatric illness such as end stage renal failure, Parkinson's disease or major depression. 3. Participation in any pharmacological or non-pharmacological (interventional) clinical trial in the preceding 12 weeks Cognitively Normal Subjects Ten (10) cognitively normal subjects will be recruited. Inclusion criteria: 1. Either male or female aged between 50 and 70 years (inclusive) 2. CDR of 0 and MMSE > 27 3. Education >6 years 4. Literate in English 5. Basic proficiency in using web-based applications/mobile platforms 6. Willing to give informed consent Exclusion criteria: 1. Significant hearing or visual impairment 2. Significant systemic, neurological or psychiatric illness such as end stage renal failure, Parkinson's disease or major depression. 3. Participation in any pharmacological or non-pharmacological clinical trial in the preceding 12 weeks Caregivers of Patients with MCI Fifteen (15) caregivers of the 30 patients with MCI will be recruited. Inclusion criteria: 1. Either male or female aged =21 years 2. Is the spouse or child of the patient and must spend at least 2 hours per week with the patient. 3. Must be healthy and not suffering from any serious systemic, neurological or psychiatric illness. 4. Literate in English 5. Willing to give informed consent Exclusion criteria: NA

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Digitally based multidomain intervention
Education (5-10 mins). This session is to educate patients on instrumental activities of daily living such as the importance of companionship, medication, finance, home, travel, and kitchen safety. The content will be delivered using video and text-based material in English. Physical Activity (10 mins). This session includes activities such as brisk walking and yoga. Participants will be allowed to choose their preferred exercise option from the menu. Reminiscence Therapy (20 mins). This session includes recollection of events using directed questions, and a collection of photos from the past. Participants will be asked to share about any aspect related to the given topics using text or audio. Cognitive Games (20 mins). Participants will be asked to play games using their fingers to control characters on the screen to achieve goals. These games are designed to train different cognitive abilities, including attention, memory, executive functioning, and processing speed.

Locations

Country Name City State
Singapore National Neuroscience Institute Singapore

Sponsors (1)

Lead Sponsor Collaborator
Neuroglee Therapeutics

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in processing speed Using Neuropsychological Test Battery (NTB) Processing Speed domain items (symbol digit modalities test, trail making test A, and Stroop test (condition 1 and 2) in patients with MCI Baseline compared to Week 11
Primary Change from baseline in executive functioning Using the NTB Executive Function domain items (digit span test, verbal fluency test, similarities test from Wechsler Adult Intelligence Scale IV (WAIS-IV) and trail making test B) in patients with MCI Baseline compared to Week 11
Primary Change from baseline in mood using the Depression Anxiety Stress Scales (DASS-21) in patients with MCI The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress.
Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content.
The scoring ranges from 0 to 3 per item. The higher the score, the greater the sense of depression, anxiety or stress.
Baseline compared to Week 11
Secondary Change from baseline in overall cognition in patients with MCI Overall cognition is tested using the Neuropsychological Test Battery (NTB). Higher scores demonstrates better performance. Baseline compared to Week 11
Secondary Change from baseline in QoL Using QOL-AD questionnaire in patients with MCI Baseline compared to Week 11
See also
  Status Clinical Trial Phase
Completed NCT04513106 - Promoting Advance Care Planning for Persons With Early-stage Dementia in the Community: a Feasibility Trial N/A
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Recruiting NCT04522739 - Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease Phase 4
Active, not recruiting NCT03167840 - Falls Prevention Through Physical And Cognitive Training in Mild Cognitive Impairment N/A
Active, not recruiting NCT03676881 - Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
Not yet recruiting NCT05041790 - A Clinical Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate Compared to Placebo in Patients With Degenerative Mild Cognitive Impairment Phase 4
Recruiting NCT04121156 - High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Patients With Mild Cognitive Impairment N/A
Recruiting NCT03605381 - MORbidity PRevalence Estimate In StrokE
Completed NCT02774083 - Cognitive Training Using Feuerstein Instrumental Enrichment N/A
Completed NCT01315639 - New Biomarker for Alzheimer's Disease Diagnostic N/A
Enrolling by invitation NCT06023446 - Can (Optical Coherence Tomography) Pictures of the Retina Detect Alzheimer's Disease at Its Earliest Stages?
Completed NCT04567745 - Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers Phase 1
Recruiting NCT05579236 - Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
Completed NCT03583879 - Using Gait Robotics to Improve Symptoms of Parkinson's Disease N/A
Terminated NCT02503501 - Intranasal Glulisine in Amnestic Mild Cognitive Impairment and Probable Mild Alzheimer's Disease Phase 2
Not yet recruiting NCT03740178 - Multiple Dose Trial of MK-4334 in Participants With Alzheimer's Clinical Syndrome (MK-4334-005) Phase 1
Active, not recruiting NCT05204940 - Longitudinal Observational Biomarker Study
Recruiting NCT02663531 - Retinal Neuro-vascular Coupling in Patients With Neurodegenerative Disease N/A
Recruiting NCT06150352 - Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
Recruiting NCT03507192 - Effects of Muscle Relaxation on Cognitive Function in Patients With Mild Cognitive Impairment and Early Stage Dementia. N/A